Table 4 Differences between SIGN Guidelines and SPC Content

Use of modified release formulations or atomoxetine should be considered where there is likelihood of diversion

Particular warnings on methylphenidate SPC about risk of misuse, diversion and related issues. In high risk cases, advised on methylphenidate SPC to use atomoxetine. Atomoxetine has no such warnings or precautions

Where atomoxetine is prescribed, clinicians should review at least 6 monthly, including assessment of ongoing efficacy and adverse effects and measurement of growth, pulse and blood pressure (with correct cuff size) using appropriate centile charts

Atomoxetine-Where patients are continuing treatment with atomoxetine beyond 1 year, re-evaluation of the need for therapy by a specialist in the treatment of ADHD is recommended. Growth and development should be monitored during treatment with atomoxetine. Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months Methylphenidate- The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. It is recommended that methylphenidate is de-challenged at least once yearly to assess the child's condition (preferable during times of school holidays). Improvement may be sustained when the drug is either temporarily or permanently discontinued. Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months. Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart

Dexamfetamine- Blood pressure should be monitored at appropriate intervals in all patients taking dexamfetamine, especially those with hypertension. Height and weight should be carefully monitored in children as growth retardation may occur

(Atomoxetine)Additional monitoring is advised for those at risk of increased cardiovascular, hepatobiliary risk, seizure risk and potential suicidal ideation

Atomoxetine- Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months. No specified requirement for hepatic or seizure monitoring.

Methylphenidate SPC-Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in Sections 4.2 and 4.4 for cardiovascular status. Cardiovascular status should be carefully monitored